CQV Consultant; Utilities & GMP Equipment

Position Summary
Experienced CQV Consultant to support a leading biotechnology client in Sacramento, California. The selected candidate will be responsible for commissioning, qualification, and validation activities related to GMP utilities, manufacturing equipment, process systems, and supporting infrastructure within a regulated biotech environment.
The role requires strong expertise in qualification lifecycle management, GMP compliance, equipment validation, and cross-functional collaboration with Engineering, Manufacturing, Quality Assurance, and Validation teams.

• Execute commissioning, qualification, and validation activities for GMP utilities and process equipment.
• Prepare, review, and execute IQ, OQ, and PQ protocols.
• Support qualification of manufacturing equipment, clean utilities, process systems, and facility infrastructure.
• Perform field verification activities and startup support during equipment commissioning.
• Review and execute turnover packages and commissioning documentation.

• Ensure qualification activities comply with GMP regulations and internal quality procedures.
• Review and approve qualification deliverables, test records, and validation reports.
• Support deviation investigations, discrepancy resolution, and CAPA implementation.
• Maintain complete traceability of qualification evidence and validation documentation.

• Work closely with Engineering, Manufacturing, Quality Assurance, Automation, and Validation teams.
• Participate in project meetings, risk assessments, and qualification planning activities.
• Provide technical recommendations during system implementation and qualification phases.

• Support CSV activities associated with equipment software, automation systems, and equipment-to-system interfaces.
• Review software configuration documentation and validation evidence.
• Assist in validation of GMP computerized systems associated with manufacturing operations.

• Bachelor's degree in engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related discipline.

• Minimum 5+ years of experience in CQV within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Hands-on experience executing IQ/OQ/PQ protocols.
• Experience with GMP manufacturing equipment and utility qualification.
• Exposure to commissioning and startup activities.

• Bioreactors
• Fermenters
• CIP/SIP Systems
• Chromatography Systems
• Process Vessels
• Filling Equipment
• Packaging Equipment

• Purified Water Systems
• Water for Injection (WFI)
• Clean Steam Systems
• HVAC Systems
• Compressed Air Systems
• Nitrogen Systems
• Environmental Monitoring Systems

• Qualification Lifecycle Management
• Risk Assessments
• Change Control
• Deviation Management
• CAPA
• Validation Documentation

• cGMP
• 21 CFR Part 11
• GAMP 5
• ICH Q9
• ICH Q10

• Biotechnology manufacturing experience.
• Experience with automation systems and SCADA interfaces.
• Exposure to Delta
  
  V, Rockwell, Siemens, or similar control systems.
• Prior experience supporting FDA, EMA, MHRA, or other regulatory inspections.
• Knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA).

• Strong technical writing and documentation skills.
• Excellent troubleshooting and problem-solving abilities.
• Effective stakeholder management and communication.
• Ability to work independently in a fast-paced GMP environment.
• Strong attention to detail and compliance mindset.